Regulatory Considerations for Environmental Monitoring Investigations

Description

Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This seminar will provide aspects to investigate in order to determine a root cause and appropriate actions to complete the report. Attendees will get an overview of environmental monitoring investigations and tools to complete an investigation.

Why Should You Attend:

Regulatory agencies review environmental monitoring programs to determine how well a facility is in a state of control. Excursions related to environmental monitoring are crucial in demonstrating this to an auditor. Investigations as results of environmental monitoring must be thorough and have the proper corrective actions put into place. The purpose of this webinar is to demonstrate how to conduct a thorough investigation and determine the proper actions to take as a result of the investigation.

Session Highlight Points:

• International regulations (ISO)
• Federal regulation (FDA, USP)
• Non-viable testing
• Viable testing
• Identification of microorganisms
• Possible sources
• Determination of a root cause
• Corrective and Preventative actions to put into place

Who Will Benefit:

• QA personnel
• Manufacturing Director/Manager/Supervisors
• Plant Manager
• R&D
• All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where environmental monitoring is done.